(a) General. Each domestic manufacturer and importer of tobacco products that are part of a class of tobacco products that is subject to regulation under chapter IX of the Federal Food, Drug, and Cosmetic Act must submit the information described in this section for such products each month beginning October 2014, and the information must be received by FDA no later than the 20th day of each month. The information must be submitted using the form that FDA provides. The information must be submitted even if the domestic manufacturer or importer had no removals subject to tax during the prior month. FDA will use the information submitted under this section and any other available information, as FDA determines appropriate, to make tobacco product user fee assessments.
(b) Contents. Each domestic manufacturer and importer must submit the following:
(1) Identification information. (i) Its name and the mailing address of its principal place of business;
(i) Its name and the mailing address of its principal place of business;
(ii) The name and a telephone number including area code of an office or individual that FDA may contact for further information;
(iii) The email address and postal address at which it wishes to receive notifications FDA sends under this part;
(iv) The Alcohol and Tobacco Tax and Trade Bureau (TTB) Permit Number(s); and
(v) The Employer Identification Number(s) (EIN).
(2) Removal information. The units of product, by class, removed and not tax exempt for the prior month and the Federal excise tax it paid, by class, for such removal.
(i) This information must be reported for each TTB tobacco permit.
(ii) If the domestic manufacturer or importer did not remove any amount of tobacco product, it must report that no tobacco product was removed into domestic commerce.
(3) Certified copies. Certified copies of the returns and forms that relate to:
(i) The removal of tobacco products into domestic commerce (as defined by section 5702 of the Internal Revenue Code of 1986); and
(ii) The payment of the Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986.